Subhajit Dey
Bengaluru
Summary
Innovative and passionate agile professional with nearly 12.5 years of experience in leading global technology teams that build and run information technology products and platforms for the life science and healthcare industry. Professionally seasoned in managing service deliveries, stakeholders, cross-functional and geographically distributed teams, vendors, and maximizing the value of the products.
Overview
12
12
years of professional experience
7
7
Certifications
Work History
Business Architect Associate Manager
Accenture
Bengaluru
2024.07 - Current
- Lead 10+ complex GxP validation projects - GAMP Cat 1,3,4 ,& 5, including LIMS, CDMS, clinical trial systems, robotic lab solutions, R&D instruments and equipment, custom-built infrastructure platforms and others.
- Strengthen Accenture–Moderna partnership by supporting leadership engagements and driving positive client relationships.
- Helped scale the CSV team from 2 to 15+ by leading screening, mentoring, onboarding, and capability-building initiatives.
- Driving organizational excellence by conducting interviews, leading cross-training programs, and ensuring compliance across teams.
Senior Analyst
Merck KGaA
Bengaluru
2022.03 - 2024.07
- Lead end-to-end CSV activities from system conception to retirement phases, and author, review, and approve respective quality documents (VP/R, FRS, DS, IQP/R, OQP/R, PQP/R, SDP/R, RA, etc.) within the Computerized Systems Lifecycle framework.
- Own or manage RFC, CAPA, deviation, non-conformance, problems, and major incidents (P1/P2) records.
- Liaise with business owners and vendor teams for activities: assessments, management presentations, and budgeting activities.
- Manage audit, IT security activities during the life cycle of systems, and ensure systems achieve and maintain regulatory requirements, 21 CFR Part 11, and adopt principles within GAMP5, Annex 11, ICH guidelines.
Functional Analyst (Service to Johnson & Johnson)
Tata Consultancy Services
Kolkata
2013.11 - 2022.03
- Responsible for agile service delivery of multiple GxP-critical applications (GAPM5 - Categories 3, 4, and 5), used 24/7 across the globe.
- Techno-functionally lead or manage teams for system development, operations—including incident, problem, service, and event management activities, CSV, and audit processes for JnJ internal business sites and 3PL manufacturing sites as a platform SPOC.
- Accountable for presenting SLA/OLA KPIs, service reviews, and project progress reports to key stakeholders.
- Facilitated agile ceremonies such as daily stand-up, sprint planning, sprint review, and the sprint retrospective meeting.
Education
PGP - Business Analytics & Business Intelligence (BABI)
McCombs School of Business & Great Lakes
India2020-11
Bachelor of Engineering - Civil Engineering
G.H. Raisoni College of Engineering
Nagpur2013-06
Skills
Computer System Validation (CSV)
IT Service Management
Quality Systems
Regulatory Labeling & Artwork
Agile Frameworks - Scrum, Kanban, & SAFe
Stakeholder Management
Service Delivery Management
Change Management
Certification
SAFe 6 Agilist (Scaled Agile, Inc. )
Timeline
Business Architect Associate Manager
Accenture
2024.07 - Current
Senior Analyst
Merck KGaA
2022.03 - 2024.07
Functional Analyst (Service to Johnson & Johnson)
Tata Consultancy Services
2013.11 - 2022.03
PGP - Business Analytics & Business Intelligence (BABI)
McCombs School of Business & Great Lakes
Bachelor of Engineering - Civil Engineering
G.H. Raisoni College of Engineering